ICU Medical CL2000S-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709071735), received between Mar 3, 2021 and Aug 18, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

60 other recalls cover devices cleared under the same FDA submission (K131549); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK PORT, WHERE A MEDWATCH REPORT WAS FILED. THE REPORTER WHO ELECTED TO NOT BE IDENTIFIED STATED DEVICE BROKE, SPILLING HAZARDOUS CHEMOTHERAPY MEDICATION WITH EMPLOYEE EXPOSURE. THERE WAS NO PATIENT INVOLVEMENT, HOWEVER THE CUSTOMER STATED AN UNSPECIFIED HARM DUE TO HAZARDOUS CHEMOTHERAPY MEDICATION WITH EMPLOYEE EXPOSURE.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250263 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED AT 5:00PM AT THE PATIENT¿S HOME AND INVOLVED AN ISSUE WITH A CHEMOLOCK AND CHEMOLOCK PORT AND AN UNPROMPTED DISCONNECT OF THE AMBULATORY PUMP RESULTING IN UNPROTECTED CHEMO EXPOSURE TO DOXORUBICINE. IT WAS REPORTED THAT THE DEVICE WAS IN USE AN HOUR WHEN A DROPLET WAS NOTED AND THERAPY WAS HALTED. THE SET UP WAS A PIGGYBACK AND THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING. THERE IS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THIS REPORT REFLECTS THE FOURTH OF FIVE EVENTS REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407816 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED AT 5:00PM AT THE PATIENT¿S HOME AND INVOLVED AN ISSUE WITH A CHEMOLOCK AND CHEMOLOCK PORT AND AN UNPROMPTED DISCONNECT OF THE AMBULATORY PUMP RESULTING IN UNPROTECTED CHEMO EXPOSURE TO DOXORUBICINE. IT WAS REPORTED THAT THE DEVICE WAS IN USE AN HOUR WHEN A DROPLET WAS NOTED AND THERAPY WAS HALTED. THE SET UP WAS A PIGGYBACK AND THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING. THERE IS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THIS REPORT REFLECTS THE THIRD OF FIVE EVENTS REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407810 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED AT 5:00PM AT THE PATIENT¿S HOME AND INVOLVED AN ISSUE WITH A CHEMOLOCK AND CHEMOLOCK PORT AND AN UNPROMPTED DISCONNECT OF THE AMBULATORY PUMP RESULTING IN UNPROTECTED CHEMO EXPOSURE TO DOXORUBICINE. IT WAS REPORTED THAT THE DEVICE WAS IN USE AN HOUR WHEN A DROPLET WAS NOTED AND THERAPY WAS HALTED. THE SET UP WAS A PIGGYBACK AND THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING. THERE IS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THIS REPORT REFLECTS THE FIFTH OF FIVE EVENTS REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407799 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED AT 5:00PM AT THE PATIENT¿S HOME AND INVOLVED AN ISSUE WITH A CHEMOLOCK AND CHEMOLOCK PORT AND AN UNPROMPTED DISCONNECT OF THE AMBULATORY PUMP RESULTING IN UNPROTECTED CHEMO EXPOSURE TO DOXORUBICINE. IT WAS REPORTED THAT THE DEVICE WAS IN USE AN HOUR WHEN A DROPLET WAS NOTED AND THERAPY WAS HALTED. THE SET UP WAS A PIGGYBACK AND THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING. THERE IS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THIS REPORT REFLECTS THE SECOND OF FIVE EVENTS REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407755 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED AT 5:00PM AT THE PATIENT¿S HOME AND INVOLVED AN ISSUE WITH A CHEMOLOCK AND CHEMOLOCK PORT AND AN UNPROMPTED DISCONNECT OF THE AMBULATORY PUMP RESULTING IN UNPROTECTED CHEMO EXPOSURE TO DOXORUBICINE. IT WAS REPORTED THAT THE DEVICE WAS IN USE AN HOUR WHEN A DROPLET WAS NOTED AND THERAPY WAS HALTED. THE SET UP WAS A PIGGYBACK AND THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING. THERE IS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, THERE WAS NO ADVERSE EVENT AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT. THIS REPORT REFLECTS THE FIRST OF FIVE EVENTS REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131549. One submission often covers many models, so check the product and lot details in each record.

• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-2210-2026 · Mar 24, 2026 · Open, Classified
  Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL
• Z-0328-2026 · Sep 8, 2025 · Open, Classified
  ChemoLock Bag Spike, 01 units REF: CL-10-10
• Z-0337-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
• Z-0348-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• Z-0360-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• Z-0336-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• Z-0359-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
• Z-0357-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• Z-0346-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• Z-0334-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

…and 45 more.